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FDA Takes Steps to Increase Availability of the Janssen COVID-19 Vaccine americanpharmaceuticalreview
June 16, 2021
Following careful review and deliberation, the U.S. FDA is taking important steps that will allow a critically needed supply of the Janssen (Johnson & Johnson) COVID-19 Vaccine to be made available.
Janssen COVID-19 Vaccine Shipment Made with Drug Substance from Emergent BioSolutions Fails QA americanpharmaceuticalreview
June 16, 2021
Health Canada has completed its quality review of the shipment of Janssen vaccines that are currently in quarantine. To protect the health and safety of Canadians in response to concerns regarding a drug substance produced at the Emergent BioSolutions ...
FDA authorises J&J Covid-19 vaccine substance made at Emergent’s plant pharmaceutical-technology
June 15, 2021
The US Food and Drug Administration (FDA) has approved, under the emergency use authorization (EUA), two batches of Johnson & Johnson (J&J) subsidiary Janssen’s Covid-19 vaccine drug substance produced at the Emergent BioSolutions’ plant in Baltimore, US.
Further woes for Emergent’s Bayview vaccine production facility europeanpharmaceuticalreview
April 26, 2021
An FDA inspection identified nine concerns including unsanitary conditions and ineffective practices for preventing cross-contamination at Emergent’s facility.
FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 Vaccines prnewswire
April 23, 2021
The U.S. Food and Drug Administration takes its responsibility to ensure medical product quality, safety and effectiveness very seriously.
FDA reports unsanitary practices at Emergent Covid-19 vaccine plant pharmaceutical-technology
April 23, 2021
The US Food and Drug Administration (FDA) has released a report citing several unsanitary practices including peeling paint, shoddy clean-ups and poorly trained staff at the Baltimore plant owned by Emergent Biosolutions (EBS), which is producing ...
FDA halts COVID-19 vaccine production at Emergent facility europeanpharmaceuticalreview
April 22, 2021
The FDA has requested Emergent’s Bayview plant be closed and vaccine production halted while the agency investigates potential good manufacturing practice (GMP) violations.
US gives charge of facility that botched COVID vaccine to J&J, stops AstraZeneca from using the plant expresspharma
April 06, 2021
AstraZeneca, whose vaccine has not been approved in the US, said it will work with President Joe Biden’s administration to find an alternative site to produce its vaccine.
Millions of J&J Covid-19 vaccine doses scrapped after US ingredient mix-up pharmaceutical-technology
April 02, 2021
Up to 15 million doses of Johnson & Johnson’s (J&J) Covid-19 vaccine have been ruined due to a mix-up with ingredients at a US production plant.
Intranasal influenza vaccine produces strong immune response, Phase I study shows europeanpharmaceuticalreview
February 07, 2021
A Phase I clinical trial has shown that Ad4-H5-VTN, a single-dose, intranasal influenza vaccine, was safe and produced an immune response.

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